FST5 - Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder.
2025-01-23
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010887638 | 3010887638 | Freespira, Inc | 1 | N | 2026-01-01 | 12020 113th Ave NE Ste 215 Kirkland WA US 98034 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B185FS059370 | FST5 - Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder. | 18007358995 | par@freespira.com |
| B185SM40500 | Freespira - Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder. | 800-735-8995 | par@freespira.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 171289 | 1293877439 | K233337 | Freespira Breathing System | SEN | 2025-04-24 |
| 171289 | 1699504106 | K180173 | Freespira | HCC | 2018-08-23 |
| 171289 | 1357667858 | K131586 | CANARY BREATHING SYSTEM | HCC | 2013-12-10 |
2025-01-23
2023-08-25